Adjustable repair chords and spool mechanism therefor

ABSTRACT

A method and device is provided, including implanting, at an intraventricular site of a ventricle of a patient, a spool coupled to a first end portion of a longitudinal member, and coupling a second end portion of the longitudinal member to a portion of tissue facing a lumen of the ventricle. Other embodiments are also described.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is related to a U.S. patent application Ser. No.12/341,960 to Cabiri, entitled, “Adjustable annuloplasty ring and spoolmechanism therefor,” filed Dec. 22, 2008, which is incorporated hereinby reference.

FIELD OF THE INVENTION

The present invention relates in general to valve and chordae tendineaerepair. More specifically, the present invention relates to repair of anatrioventricular valve and associated chordae tendineae of a patient.

BACKGROUND OF THE INVENTION

Ischemic heart disease causes mitral regurgitation by the combination ofischemic dysfunction of the papillary muscles, and the dilatation of theleft ventricle that is present in ischemic heart disease, with thesubsequent displacement of the papillary muscles and the dilatation ofthe mitral valve annulus.

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Mitral regurgitation ofblood from the left ventricle into the left atrium results in increasedtotal stroke volume and decreased cardiac output, and ultimate weakeningof the left ventricle secondary to a volume overload and a pressureoverload of the left atrium.

Chronic or acute left ventricular dilatation can lead to papillarymuscle displacement with increased leaflet tethering due to tension onchordae tendineae, as well as annular dilatation.

U.S. Pat. No. 7,431,692 to Zollinger et al. describes an adjustablesupport pad for adjustably holding a tensioning line used to applytension to a body organ. The adjustable support pad can include alocking mechanism for preventing slidable movement of the tensioningelement in one or both directions. The locking mechanism may includespring-loaded locks, rotatable cam-like structures, and/or rotatablespool structures. The adjustable support pad may be formed from rigid,semi-rigid, and/or flexible materials, and may be formed to conform tothe outer surface of a body organ. The adjustable support pad can beconfigured to adjustably hold one or more separate tensioning lines, andto provide for independent adjustment of one or more tensioning lines orgroups thereof.

US Patent Application Publication 2007/0118151 to Davidson describes amethod and system to achieve leaflet coaptation in a cardiac valvepercutaneously by creation of neochordae to prolapsing valve segments.This technique is especially useful in cases of ruptured chordae, butmay be utilized in any segment of prolapsing leaflet. The techniquedescribed herein has the additional advantage of being adjustable in thebeating heart. This allows tailoring of leaflet coaptation height undervarious loading conditions using image-guidance, such asechocardiography. This offers an additional distinct advantage overconventional open-surgery placement of artificial chordae. Intraditional open surgical valve repair, chord length must be estimatedin the arrested heart and may or may not be correct once the patient isweaned from cardiopulmonary bypass. The technique described below alsoallows for placement of multiple artificial chordae, as dictated by thepatient's pathophysiology.

The following patents and patent application publications, relevantportions of which are incorporated herein by reference, may be ofinterest:

-   PCT Patent Application Publication WO 07/136783 to Cartledge et al.-   U.S. Pat. No. 5,306,296 to Wright et al.-   U.S. Pat. No. 6,569,198 to Wilson et al.-   U.S. Pat. No. 6,619,291 to Hlavka et al.-   U.S. Pat. No. 6,764,510 to Vidlund et al.-   U.S. Pat. No. 7,004,176 to Lau-   U.S. Pat. No. 7,101,395 to Tremulis et al.-   U.S. Pat. No. 7,175,660 to Cartledge et al.-   US Patent Application Publication 2003/0050693 to Quijano et al-   US Patent Application Publication 2003/0167062 to Gambale et al.-   US Patent Application Publication 2004/0024451 to Johnson et al.-   US Patent Application Publication 2004/0148021 to Cartledge et al.-   US Patent Application Publication 2004/0236419 to Milo-   US Patent Application Publication 2005/0171601 to Cosgrove et al.-   US Patent Application Publication 2005/0288781 to Moaddeb et al.-   US Patent Application Publication 2007/0016287 to Cartledge et al.-   US Patent Application Publication 2007/0080188 to Spence et al.

The following articles, which are incorporated herein by reference, maybe of interest:

-   O'Reilly S et al., “Heart valve surgery pushes the envelope,”    Medtech Insight 8(3): 73, 99-108 (2006)-   Dieter R S, “Percutaneous valve repair: Update on mitral    regurgitation and endovascular approaches to the mitral valve,”    Applications in Imaging, Cardiac Interventions, Supported by an    educational grant from Amersham Health pp. 11-14 (2003)

SUMMARY OF THE INVENTION

In some embodiments of the present invention, subvalvular apparatus isprovided comprising adjustable repair chords and a delivery tool forimplantation thereof. The repair chords comprise one or morelongitudinal members, e.g., sutures, wires, or elongate tensioningcoils, which are coupled at respective first end portions thereof to anadjusting mechanism. In some embodiments, the repair chords function asartificial chordae tendineae. For some application, the repair chordsare used to adjust a distance between two portions of the ventricularwall. The adjusting mechanism comprises a spool assembly which comprisesa housing which houses a spool to which the first end portion of thelongitudinal member is coupled. Typically, the longitudinal member iscoupled to, e.g., knotted to or looped through, the spool such that thelongitudinal member defines a first end portion thereof that is coupledto the spool and at least one free end of the longitudinal member. Thehousing of the adjusting mechanism is coupled to a tissue anchor whichfacilitates implantation of the adjusting mechanism in a first portionof tissue of the heart which faces and surrounds the ventriclular lumen,e.g., a papillary muscle or a first portion of a ventricular wall of theheart. Following implantation of the adjusting mechanism at theimplantation site, the operating physician couples (e.g., ties, sutures,clips, or otherwise fastens) the free end of the longitudinal member toa second portion of tissue which faces and surrounds the ventricle,e.g., a leaflet of an atrioventricular valve or a second portion of theventricular wall.

Once the free end of the longitudinal member is coupled to the secondportion of tissue of the heart that faces and surrounds the ventricle,the operating physician rotates the spool in order to adjust a length ofthe longitudinal member. During the rotation of the spool in a firstdirection thereof, the longitudinal member is wound around the spoolthereby shortening and tensioning the longitudinal member. Responsively,the ends of the longitudinal member coupled to the second portion ofheart tissue, and consequently the second portion of tissue, are pulledtoward the adjusting mechanism at the implantation site. Thus, forembodiments in which the repair chord functions as an artificial chordaetendineae, the longitudinal member replaces slackened native chordaetendineae and restores normal function to the atrioventricular valve.

The adjusting mechanism comprises a reversible locking mechanism whichfacilitates bidirectional rotation of the spool in order to effect bothtensioning and relaxing of the longitudinal member. That is, the spoolis wound in one direction in order to tighten the longitudinal member,and in an opposite direction in order to slacken the longitudinalmember. Thus, the spool adjusting mechanism facilitates bidirectionaladjustment of the repair chord.

The delivery tool comprises a handle and a multilumen shaft that iscoupled at a distal end thereof to the adjusting mechanism. The deliverytool functions to advance the adjusting mechanism to the implantationsite, implant the adjusting mechanism at the implantation site, andeffect adjustment of the repair chord by effecting rotation of thespool. The multilumen shaft defines a primary lumen which houses anelongate torque-delivering tool and is slidable with respect to a shaftof the elongate torque-delivering tool. For embodiments in which therepair chord functions as artificial chordae tendineae, prior toimplantation of the adjusting mechanism, the distal portion of thedelivery tool and the adjusting mechanism coupled thereto are advancedbetween the leaflets of the atrioventricular valve and into theventricle toward the implantation site. During the implantation of theadjusting mechanism, the multilumen shaft is disposed around the portionof the torque-delivering tool that is positioned in the ventricle. Priorto the subsequent rotation of the spool, the multilumen shaft is pulledproximally with respect to the torque-delivering tool that is left inplace during the pulling. The multilumen shaft is pulled such that adistal end thereof is disposed proximal to the valve and in the atrium.

The incision made in the heart is then closed around the delivery tooland the heart resumes its normal function during the adjustment of thelength of the artificial chordae. The retracting of the multilumen shaftreduces a diameter of the delivery tool at the portion thereof that isdisposed between the leaflets of the valve. Such reducing of thediameter reduces the interference of the portion of the delivery tool onthe beating heart valve and the adjustment of the artificial chordae isperformed with minimal interference to the valve by the delivery tool.

In some embodiments, apparatus and method described herein may be usedfor providing artificial chordae tendineae in a left ventricle of theheart and effecting adjustment thereof. In some embodiments, apparatusand method described herein may be used for providing artificial chordaetendineae in a right ventricle of the heart and effecting adjustmentthereof. In some embodiments, apparatus and method described herein maybe used for providing a system to adjust a length between two portionsof the heart wall.

There is therefore provided, in accordance with an embodiment of thepresent invention, a method, including:

implanting, at an intraventricular site of a ventricle of a patient, aspool coupled to a first end portion of a longitudinal member; and

coupling a second end portion of the longitudinal member to a portion oftissue facing a lumen of the ventricle.

In an embodiment, the method includes transcatheterally advancing thespool toward the intraventricular site.

In an embodiment, the method includes advancing the spool toward theintraventricular site during an open-heart procedure.

In an embodiment, the method includes advancing the spool toward theintraventricular site during a minimally-invasive procedure.

In an embodiment, coupling the second end portion of the longitudinalmember to the portion of tissue facing the ventricular lumen includescoupling the second end portion of the longitudinal member to a leafletof an atrioventricular valve of the patient.

In an embodiment, implanting the spool in the intraventricular siteincludes suturing the spool to the intraventricular site.

In an embodiment, the spool is coupled to a tissue anchor, andimplanting the spool in the intraventricular site includes implantingthe tissue anchor in tissue of the ventricle in a manner in which adistal end of the tissue anchor is disposed within the tissue of theventricle and does not extend beyond a pericardium of a heart of thepatient.

In an embodiment:

implanting the spool includes implanting the spool at a first portion oftissue facing the ventricular lumen,

coupling the second end portion of the longitudinal member to theportion of tissue includes coupling the second end portion of thelongitudinal member to a second portion of tissue facing the ventricularlumen, and

the method further includes:

-   -   rotating the spool in a first direction thereof,    -   by the rotating of the spool, winding a portion of the        longitudinal member around the spool,    -   by the winding of the portion, shortening a length of the        longitudinal member, and    -   by the shortening of the length of the longitudinal member,        drawing together the first and second portions of the tissue        facing the ventricular lumen of the patient.

In an embodiment:

implanting the spool at the first portion of tissue includes implantingthe spool at a papillary muscle of a left ventricle of the patient,

coupling the second end portion of the longitudinal member to the secondportion of tissue includes coupling the second end portion of thelongitudinal member to a leaflet of a mitral valve of the patient, and

drawing together the first and second portions of the tissue facing theventricular lumen includes drawing the leaflet toward the papillarymuscle.

In an embodiment:

implanting the spool at the first portion of tissue includes implantingthe spool at a papillary muscle of a right ventricle of the patient,

coupling the second end portion of the longitudinal member to the secondportion of tissue includes coupling the second end portion of thelongitudinal member to a leaflet of a tricuspid valve of the patient,and

drawing together the first and second portions of the tissue facing theventricular lumen includes drawing the leaflet toward the papillarymuscle.

In an embodiment:

implanting the spool at the first portion of tissue includes implantingthe spool at a first portion of tissue of an inner wall of a leftventricle of the patient,

coupling the second end portion of the longitudinal member to the secondportion of tissue includes coupling the second end portion of thelongitudinal member to a leaflet of a mitral valve of the patient, and

drawing together the first and second portions of the tissue facing theventricular lumen includes drawing the leaflet toward the first portionof tissue of the inner wall of the ventricle.

In an embodiment:

implanting the spool at the first portion of tissue includes implantingthe spool at a first portion of an inner wall of a right ventricle ofthe patient,

coupling the second end portion of the longitudinal member to the secondportion of tissue includes coupling the second end portion of thelongitudinal member to a leaflet of a tricuspid valve of the patient,and

drawing together the first and second portions of the tissue facing theventricular lumen includes drawing the leaflet toward the first portionof tissue of the inner wall of the ventricle.

In an embodiment:

implanting the spool at the first portion of tissue includes implantingthe spool at a first portion of an inner wall of the ventricle of thepatient,

coupling the second end portion of the longitudinal member to the secondportion of tissue includes coupling the second end portion of thelongitudinal member to a second portion of the inner wall of theventricle of the patient, and

drawing together the first and second portions of the tissue facing theventricular lumen includes drawing the first and second portions oftissue of the inner wall of the ventricle toward each other.

In an embodiment:

implanting the spool at the first portion of tissue includes implantingthe spool at a papillary of the ventricle of the patient,

coupling the second end portion of the longitudinal member to the secondportion of tissue includes coupling the second end portion of thelongitudinal member to a portion of an inner wall of the ventricle ofthe patient, and

drawing together the first and second portions of the tissue facing theventricular lumen includes drawing the papillary muscle and the portionof tissue of the inner wall of the ventricle toward each other.

In an embodiment, implanting the spool coupled to the first end portionof the longitudinal member includes implanting a spool coupled to atleast first and second longitudinal members at respective first endportions thereof, each longitudinal member having respective second endportions thereof, and the method further includes:

coupling the second end portion of the first longitudinal member to afirst portion of heart tissue facing the ventricular lumen,

coupling the second end portion of the second longitudinal member to asecond portion of heart tissue facing the ventricular lumen, and

drawing the first and second portions of heart tissue toward each other.

In an embodiment, implanting the spool includes implanting the spool ata papillary muscle.

In an embodiment, implanting the spool includes implanting the spool ata portion of tissue of an inner wall of the ventricle facing theventricular lumen.

In an embodiment:

coupling the second end portion of the first longitudinal member to thefirst portion of tissue includes coupling the second end portion of thefirst longitudinal member to a first portion of an inner wall of theventricle,

coupling the second end portion of the second longitudinal member to thesecond portion of tissue includes coupling the second end portion of thesecond longitudinal member to a second portion of an inner wall of theventricle, and

drawing the first and second portions of heart tissue toward each otherincludes drawing together the first and second portions of the innerwall of the ventricle.

In an embodiment:

coupling the second end portion of the first longitudinal member to thefirst portion of tissue includes coupling the second end portion of thefirst longitudinal member to a portion of an inner wall of theventricle,

coupling the second end portion of the second longitudinal member to thesecond portion of tissue includes coupling the second end portion of thesecond longitudinal member to a papillary muscle of the ventricle, and

drawing the first and second portions of heart tissue toward each otherincludes drawing the portion of the inner wall of the ventricle and thepapillary muscle toward each other.

In an embodiment:

coupling the second end portion of the first longitudinal member to thefirst portion of tissue includes coupling the second end portion of thefirst longitudinal member to a leaflet of an atrioventricular valve,

coupling the second end portion of the second longitudinal member to thesecond portion of tissue includes coupling the second end portion of thesecond longitudinal member to a papillary muscle of the ventricle, and

drawing the first and second portions of heart tissue toward each otherincludes drawing the leaflet and the papillary muscle toward each other.

In an embodiment:

coupling the second end portion of the first longitudinal member to thefirst portion of tissue includes coupling the second end portion of thefirst longitudinal member to a leaflet of an atrioventricular valve,

coupling the second end portion of the second longitudinal member to thesecond portion of tissue includes coupling the second end portion of thesecond longitudinal member to a portion of an inner wall of theventricle, and

drawing the first and second portions of heart tissue toward each otherincludes drawing the leaflet and the portion of the inner wall towardeach other.

In an embodiment:

coupling the second end portion of the first longitudinal member to thefirst portion of tissue includes coupling the second end portion of thefirst longitudinal member to a first leaflet of an atrioventricularvalve.

coupling the second end portion of the second longitudinal member to thesecond portion of tissue includes coupling the second end portion of thesecond longitudinal member to a second leaflet of the atrioventricularvalve, and

drawing the first and second portions of heart tissue toward each otherincludes drawing the first and second leaflets toward each other.

In an embodiment, the method includes advancing the spool toward theintraventricular site by advancing a portion of a delivery tool that isreversibly coupled to the spool between leaflets of an atrioventricularvalve having at least first and second leaflets thereof, and implantingthe spool at the intraventricular site includes manipulating thedelivery tool to implant the spool at the intraventricular site.

In an embodiment, the method includes:

following the implanting of the spool:

-   -   decoupling the delivery tool from the spool,    -   removing the delivery tool from the ventricle, and    -   subsequently to the removing, accessing the spool at the        intraventricular site.

In an embodiment, accessing the spool includes recoupling the deliverytool to the spool by advancing the delivery tool along at least oneguide wire coupled to the spool.

In an embodiment, accessing the spool comprises coupling atorque-delivering-tool to the spool by advancing thetorque-delivering-tool through an elongate tube coupled at a first endthereof to the spool and at second end thereof to a portion ofsubcutaneous tissue of the patient.

In an embodiment, the method includes:

following the coupling of the second end portion of the longitudinalmember to the portion of tissue facing the ventricular lumen:

-   -   sliding a shaft of the delivery tool with respect to a        torque-delivering tool of the delivery tool, and sliding a        proximal portion of the shaft into a lumen of a handle portion        of the delivery tool; and    -   subsequently to the sliding, rotating the spool in the first        direction thereof.

In an embodiment, sliding the shaft includes:

sliding the shaft until a distal portion of the shaft is disposedproximally to the atrioventricular valve, and

responsively, reducing a diameter of the portion of the delivery tooldisposed between the leaflets of the valve.

In an embodiment, reducing the diameter of the portion of the deliverytool disposed between the leaflets of the valve includes reducing thediameter to between 0.8 mm and 1.5 mm.

In an embodiment:

implanting the spool includes implanting:

-   -   a spool coupled to a mechanical locking element having a surface        coupled to the lower surface of the rotatable structure,

and the method further includes:

-   -   advancing an elongate tool through a channel provided by the        spool;    -   unlocking the spool from the mechanical locking element by        pushing a depressible portion of the surface of the locking        element;    -   responsively to the pushing of the depressible portion,        dislodging a protrusion protruding out of a plane of the surface        of the mechanical element from within a recess defined by the        spool; and    -   rotating the spool.

In an embodiment:

during a first period:

-   -   in response to the pushing of the elongate tool, maintaining the        protrusion in a position in which it is dislodged from the        recess, and    -   rotating the spool;

during a second period:

-   -   removing the elongate tool from within the channel and        facilitating positioning of the protrusion in the recess, and    -   restricting rotation of the spool.

There is further provided, in accordance with an embodiment of thepresent invention, apparatus, including:

a delivery tool including:

-   -   a handle portion defining a handle lumen; and    -   a shaft (a) being slidable with respect to the handle, and (b)        having a proximal portion thereof being slidable into the handle        lumen during proximal sliding of the shaft;

a spool reversibly couplable to the distal end of the delivery tool andconfigured to be implanted in an intraventricular site of a ventricle ofa patient; and

a longitudinal member having opposite first and second end portionsthereof, the first portion being coupled to the spool and the second endportion configured to be coupled to a first portion of heart tissue thatsurrounds a ventricular space of the ventricle of the patient, thelongitudinal member:

-   -   in response to rotation of the spool in a first direction        thereof, configured to be wound around the spool, and,        responsively, to draw the second end portion of the longitudinal        member and the first portion of heart tissue toward the first        end portion of the longitudinal member.

In an embodiment, the shaft is shaped to provide at least one secondarylumen configured for housing a section of the longitudinal member thatis between the first and second end portions thereof.

In an embodiment, the longitudinal member includes expandedpolytetrafluoroethylene (ePTFE).

In an embodiment, at least a portion of the longitudinal member isshaped to define a coil, and the coil is configured to apply atensioning force to the first portion of heart tissue.

In an embodiment, the longitudinal member is coated withpolytetrafiuoroethylene.

In an embodiment, the apparatus includes, a locking mechanism coupled tothe implant structure and configured to restrict rotation of the spool.

In an embodiment:

the apparatus includes include at least first and second longitudinalmembers having respective first and second end portions thereof,

-   -   the first end portions of the first and second longitudinal        members are coupled to the spool,    -   the second end portion of the first longitudinal member is        configured to be coupled to a leaflet of an atrioventricular        valve,    -   the second end portion of the second longitudinal member is        configured to be coupled to a portion of tissue of an inner wall        of the ventricle, and    -   in response to rotation of the spool, the first and second        longitudinal members are tightened and pull the leaflet toward        the portion of tissue of the inner wall.

In an embodiment:

the apparatus includes include at least first and second longitudinalmembers having respective first and second end portions thereof,

the first end portions of the first and second longitudinal members arecoupled to the spool,

the second end portion of the first longitudinal member is configured tobe coupled to the leaflet of the valve,

the second end portion of the second longitudinal member is configuredto be coupled to a papillary muscle of the ventricle, and

in response to rotation of the spool, the first and second longitudinalmembers are tightened and pull the leaflet toward the papillary muscle.

In an embodiment:

the apparatus includes include at least first and second longitudinalmembers having respective first and second end portions thereof,

the first end portions of the first and second longitudinal members arecoupled to the spool,

the second end portion of the first longitudinal member is configured tobe coupled to a first portion of tissue of an inner wall of theventricle,

the second end portion of the second longitudinal member is configuredto be coupled to a second portion of tissue of the inner wall of theventricle, and

in response to rotation of the spool, the first and second longitudinalmembers are tightened and pull the first and second portions of tissueof the inner wall toward each other.

In an embodiment, the apparatus includes an elongate tube coupled at afirst end to the spool and at a second end thereof to subcutaneoustissue of the patient, the elongate tube is configured to facilitateaccessing of a torque-delivering-tool to the spool following (a) theimplantation of the spool at the intraventricular site and (b)subsequent removal of the delivery tool.

In an embodiment, the spool is configured to be coupled to a secondportion of heart tissue that surrounds the ventricular space, and, inresponse to the rotation of the spool, the longitudinal member isconfigured to draw the first and second portions of heart tissue towardeach other.

In an embodiment:

the first portion of heart tissue includes a first portion of an innerwall of the ventricle,

the second end portion of the longitudinal member is configured to becoupled to the first portion of the inner wall of the ventricle, and

in response to the rotation of the spool, the longitudinal member isconfigured to draw the first portion of the inner wall of the ventricletoward the second portion of heart tissue.

In an embodiment:

the second portion of heart tissue includes a papillary muscle of theventricle,

the spool is configured to be coupled to the papillary muscle, and

in response to the rotation of the spool, the longitudinal member isconfigured to draw the first portion of the inner wall of the ventricletoward the papillary muscle.

In an embodiment:

the second portion of heart tissue includes a second portion of theinner wall of the ventricle,

the spool is configured to be coupled to the second portion of the innerwall of the ventricle, and

in response to the rotation of the spool, the longitudinal member isconfigured to draw the first and second portions of the inner wall ofthe ventricle toward each other.

In an embodiment:

the first portion of heart tissue includes a leaflet of a mitral valveof the patient,

the second end portion of the longitudinal member is configured to becoupled to the leaflet of the mitral valve of the patient,

the second portion of heart tissue includes tissue of a papillary muscleof a left ventricle,

the spool is configured to be implanted in the tissue of the papillarymuscle of the left ventricle, and

the spool is configured to adjust a length of the longitudinal memberbetween the papillary muscle and the leaflet of the mitral valve.

In an embodiment:

the first portion of heart tissue includes a leaflet of a mitral valveof the patient,

the second end portion of the longitudinal member is configured to becoupled to the leaflet of the mitral valve of the patient,

the second portion of heart tissue includes a second portion of an innerwall of a left ventricle,

the spool is configured to be coupled to the second portion of the innerwall of the left ventricle, and

the spool is configured to adjust a length of the longitudinal memberbetween the second portion of the inner wall and the leaflet of themitral valve.

In an embodiment:

the first portion of heart tissue includes a leaflet of a tricuspidvalve of the patient,

the second end portion of the longitudinal member is configured to becoupled to the leaflet of the tricuspid valve of the patient,

the second portion of heart tissue includes tissue of a papillary muscleof a right ventricle,

the spool is configured to be implanted in the tissue of the papillarymuscle of the right ventricle, and

the spool is configured to adjust a length of the longitudinal memberbetween the papillary muscle and the leaflet of the tricuspid valve.

In an embodiment:

the first portion of heart tissue includes a leaflet of a tricuspidvalve of the patient,

the second end portion of the longitudinal member is configured to becoupled to the leaflet of the tricuspid valve of the patient,

the second portion of heart tissue includes a second portion of an innerwall of a right ventricle,

the spool is configured to be coupled to the second portion of the innerwall of the right ventricle, and

the spool is configured to adjust a length of the longitudinal memberbetween the second portion of the inner wall and the leaflet of thetricuspid valve.

In an embodiment, the apparatus includes at least one guide wire coupledto the spool, and, subsequently to the implantation of the spool, thedelivery tool is configured to be:

decoupled from the spool and removed from the ventricle, and

advanceable along the guide wire.

In an embodiment, the guide wire is configured to facilitate access of atorque-delivering-tool to the spool following the implantation of thespool at the intraventricular site.

In an embodiment, the apparatus includes a torque-delivering-tool, and:

the shaft is shaped to define at least a primary lumen,

the torque-delivering-tool is disposed in the primary lumen and iscoupled at a proximal end thereof to the handle, and

the shaft is slidable with respect to the torque-delivering-tool.

In an embodiment, the delivery tool is configured to be advanceablebetween leaflets of an atrioventricular valve of the patient, and theshaft is slidable with respect to the torque-delivering-tool in a mannerthat reduces a diameter of a portion of the delivery tool that isdisposed between the leaflets of the valve.

In an embodiment, the handle lumen has a handle-lumen-length of between50 mm and 100 mm, and the shaft is slidable in a first direction thereofto advance the proximal portion thereof into the lumen of the deliverytool.

In an embodiment, the distal portion of the torque-delivering tool isconfigured to be positioned within the ventricular space of the heartand defines a torque-delivering-tool-length at the distal portion ofbetween 50 mm and 100 mm, and a ratio of the handle-lumen-length and thetorque-delivering-tool-length at the distal portion is between 0.7:1 and1.3:1.

In an embodiment:

the first portion of heart tissue includes an atrioventricular valvehaving at least first and second leaflets thereof,

the apparatus includes include at least first and second longitudinalmembers having respective first and second end portions thereof,

the first end portions of the first and second longitudinal members arecoupled to the spool,

the second end portion of the first longitudinal member is configured tobe coupled to the first leaflet of the valve,

the second end portion of the second longitudinal member is configuredto be coupled to the second leaflet of the valve, and

in response to rotation of the spool, the first and second longitudinalmembers are tightened and pull on the respective second end portionsthereof toward the spool.

In an embodiment, in response to rotation of the spool in a firstdirection thereof, the respective first end portions of the first andsecond longitudinal members are configured to be wound around the spool,and, responsively, to pull the respective second end portions of thefirst and second longitudinal members toward the spool, and responsivelyto draw the first and second leaflets toward each other.

In an embodiment:

the spool has a first end shaped to define a first opening, and a secondend shaped to define a second opening, the spool being shaped to definea channel extending from the first opening to the second opening, thechannel being configured for passage therethrough of an elongaterotation tool, and

the second end of the spool has a lower surface thereof shaped to:

-   -   provide at least a portion thereof having a circumference, and    -   define one or more recesses at locations along the        circumference.

In an embodiment, the apparatus includes a mechanical element having asurface coupled to the lower surface of the spool, the mechanicalelement being shaped to provide:

-   -   a protrusion protruding out of a plane of the surface of the        mechanical element, the protrusion being disposed within one of        the recesses during a resting state of the mechanical element,        in a manner that restricts rotation of the spool, and    -   a depressible portion coupled to the protrusion, the depressible        portion being disposed in communication with the second opening        of the lower surface, and configured to dislodge the protrusion        from within the recess in response to a force applied thereto by        the elongate tool.

In an embodiment, the apparatus includes a housing surrounding thespool, the housing being coupled in part to a cap having a surface thatis disposed in parallel with the lower surface of the spool, and thedepressible portion is disposed between the lower surface of therotatable structure and the cap.

In an embodiment, the apparatus includes a housing surrounding thespool, the housing being shaped to define a recessed portion thereofconfigured to receive the protrusion during the resting state of themechanical element.

In an embodiment, the apparatus includes a torque-delivering-tooldisposed within a primary lumen of the shaft, the torque-delivering toolis coupled at a distal end thereof to the elongate rotation tool, andthe torque-delivering tool is configured to facilitate rotation of thespool by facilitating rotation of the elongate tool.

In an embodiment:

during a first period:

-   -   the torque-delivering-tool is configured to maintain the        protrusion in a position in which it is dislodged from the        recess, and    -   the torque-delivering-tool is configured to rotate the spool,        and during a second period:

the torque-delivering-tool is configured to remove the elongate toolfrom the channel and to position the protrusion in the recess, and

the spool is restricted from being rotated.

There is additionally provided, in accordance with an embodiment of thepresent invention, apparatus, including:

a rotatable structure having a first end shaped to define a firstopening, and a second end shaped to define a second opening, therotatable structure being shaped to define a channel extending from thefirst opening to the second opening, the channel being configured forpassage therethrough of an elongate tool, and the second end of thestructure having a lower surface thereof shaped to:

-   -   provide at least a portion thereof having a circumference, and    -   define one or more recesses at locations along the        circumference; and

a mechanical element having a surface coupled to the lower surface ofthe rotatable structure, the mechanical element being shaped to provide:

a protrusion protruding out of a plane of the surface of the mechanicalelement, the protrusion being disposed within one of the recesses duringa resting state of the mechanical element, in a manner that restrictsrotation of the rotatable structure, and

a depressible portion coupled to the protrusion, the depressible portionbeing disposed in communication with the second opening of the lowersurface, and configured to dislodge the protrusion from within therecess in response to a force applied thereto by the elongate tool.

In an embodiment:

during a first period:

-   -   the elongate tool is configured to maintain the protrusion in a        position in which it is dislodged from the recess, and    -   the elongate tool is configured to rotate the rotatable        structure, and during a second period:    -   the elongate tool is configured to remove the elongate tool from        the channel and to position the protrusion in the recess, and    -   the rotatable structure is restricted from being rotated.

In an embodiment, the apparatus includes a housing surrounding therotatable structure, the housing being coupled in part to a cap having asurface that is disposed in parallel with the lower surface of therotatable structure, and the depressible portion is disposed between thelower surface of the rotatable structure and the cap.

In an embodiment, the apparatus includes a housing surrounding therotatable structure, the housing being shaped to define a recessedportion thereof configured to receive the protrusion during the restingstate of the mechanical element.

In an embodiment, the rotatable structure includes a spool, and theapparatus further includes a longitudinal member configured to becoupled at at least a first end portion thereof to the spool and to bewrapped around the spool in response to rotation of the spool in a firstdirection thereof.

In an embodiment

during a first period:

-   -   the elongate tool is configured to maintain the protrusion in a        position in which it is dislodged from the recess, and    -   the elongate tool is configured to rotate the spool, and during        a second period:    -   the elongate tool is configured to remove the elongate tool from        the channel and to position the protrusion in the recess, and    -   the spool is restricted from being rotated.

In an embodiment:

the spool is configured for implantation in a first portion of hearttissue that defines a ventricular lumen of the ventricle of a patient,

the longitudinal member is configured to be coupled at a second endportion thereof to a second portion of heart tissue that defines aventricular lumen of the ventricle of the patent, and

in response to rotation of the spool in a first direction thereof, thelongitudinal member is configured to be wound around the spool, and,responsively, to shorten a distance between the second end portion ofthe longitudinal member and the spool.

There is yet additionally provided, in accordance with an embodiment ofthe present invention, a method, including:

providing a rotatable structure coupled to a mechanical locking elementhaving a surface coupled to the lower surface of the rotatablestructure;

implanting the rotatable structure in cardiac tissue;

advancing an elongate tool through a channel provided by the rotatablestructure;

unlocking the rotatable structure from the mechanical locking element bypushing a depressible portion of the surface of the locking element;

responsively to the pushing of the depressible portion, dislodging aprotrusion protruding out of a plane of the surface of the mechanicalelement from within a recess defined by the rotatable structure; and

rotating the rotatable structure.

In an embodiment:

during a first period:

-   -   in response to the pushing of the elongate tool, maintaining the        protrusion in a position in which it is dislodged from the        recess; and    -   rotating the rotating structure; and

during a second period:

-   -   removing the elongate tool from within the channel and        facilitating positioning of the protrusion in the recess; and    -   restricting rotation of the rotatable structure.

There is still further provided, in accordance with an embodiment of thepresent invention, an implant delivery tool, including:

an implant-coupling portion;

a handle portion;

an elongate delivery tool shaft coupled at a proximal end thereof to thehandle portion and at a distal end thereof to the implant-couplingportion; and

a needle holder coupled along a portion of the shaft between theimplant-coupling portion and the handle, the needle holder being shapedto define at least one slit for receiving a needle.

In an embodiment, the apparatus includes an implant structure includingat least one longitudinal member coupled at a free end thereof to aneedle.

In an embodiment, the longitudinal member extends along the shaft towardthe needle holder, and the needle holder is shaped to provide aprojection thereof configured for winding excess portions of thelongitudinal member therearound.

In an embodiment, the handle portion is shaped to define a handle lumen,and a proximal portion of the shaft is configured for slidableadvancement within the handle lumen of the handle portion.

In an embodiment, the handle lumen has a handle-lumen-length of between50 mm and 100 mm, and the shaft is slidable in a first direction thereofto advance the proximal portion thereof into the lumen of the deliverytool.

There is also provided, in accordance with an embodiment of the presentinvention apparatus, including:

an intraventricular adjusting assembly configured to be implanted in anintraventricular site of a ventricle of a patient;

an elongate coupling tube coupled at a first end thereof to theintraventricular adjusting assembly and at second end thereof to aportion of subcutaneous tissue of the patient; and

an extracardiac tool configured to access the adjusting assembly from asite external to a body of the patient.

There is additionally provided, in accordance with an embodiment of thepresent invention, a method, including:

implanting an adjusting assembly configured in an intraventricular siteof a ventricle of a patient;

accessing the adjusting assembly by an extracardiac tool from a siteexternal to a body of the patient by passing the tool through anelongate coupling tube that is coupled at a first end thereof to theintraventricular adjusting assembly and at second end thereof to aportion of subcutaneous tissue of the patient.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of respective portions of a deliverytool system for implanting and adjusting repair chords, in accordancewith an embodiment of the present invention;

FIG. 2 is a schematic illustration of the delivery tool system of FIG.1, in accordance with an embodiment of the present invention;

FIG. 3 is a schematic illustration of a spool assembly coupled to adistal end of the delivery tool of FIG. 1, in accordance with anembodiment of the present invention;

FIGS. 4A-C are schematic illustrations of respective components of anadjusting mechanism of the spool assembly of FIG. 3, in accordance withan embodiment of the present invention;

FIGS. 5A-G are schematic illustrations of a procedure for using thedelivery tool to implant the spool assembly at a papillary muscle andadjust the repair chords, in accordance with an embodiment of thepresent invention;

FIG. 6 is a schematic illustration of a port mechanism being coupled tothe spool assembly, in accordance with an embodiment of the presentinvention;

FIG. 7 is a schematic illustration of the spool assembly and the repairchords, in accordance with an embodiment of the present invention;

FIG. 8 is a schematic illustration of the adjusting mechanism beingimplanted at a portion of a ventricular wall, in accordance with anembodiment of the present invention;

FIGS. 9, 10A-B, and 11 are schematic illustrations of the repair chordsused to draw portions of a ventricular wall toward each other, inaccordance with an embodiment of the present invention; and

FIGS. 12A-B are schematic illustrations of the repair chords used todraw together leaflets of an atrioventricular valve, in accordance withan embodiment of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made to FIGS. 1-2, which are schematic illustrations ofa system 10 comprising apparatus for implanting and adjusting repairchords in a heart of a patient, in accordance with an embodiment of thepresent invention. FIG. 1 is a schematic illustration of a portion ofthe respective components of system 10 showing the relationship betweenthe components. System 10 comprises a delivery tool 20 having a proximalhandle portion 24 and an elongate multilumen shaft 22. System 10comprises an implant structure comprising a spool assembly 240 that isreversibly couplable to a distal portion of delivery tool 20. Spoolassembly 240 comprises an adjusting mechanism 40 that is coupled to atissue anchor 50. Tissue anchor 50 is shown as a helical anchor by wayof illustration and not limitation, and may comprise staples, clips,spring-loaded anchors, or other tissue anchors known in the art.Alternatively, spool assembly 240 does not include tissue anchor 50 andis, instead, sutured to a portion of tissue of a ventricle wall whichfaces a ventricular lumen of a heart of a patient.

Shaft 22 comprises a multilumen shaft defining a primary lumensurrounding a torque-delivering-tool 26 which is surrounded by anovertube 90 (as shown in the transverse cross-section of tool 22 in FIG.2). Torque-delivering-tool 26 is coupled at a proximal end thereof to arotating structure 32 that is coupled to handle 24 and, in response torotation thereof, functions to deliver torque to torque-delivering-tool26. Torque-delivering-tool 26 rotates in response to rotation ofrotating structure 32 and delivers torque to adjusting mechanism 40coupled to the distal end of tool 20. (In this context, in thespecification and in the claims, “proximal” means closer to the orificethrough which tool 20 is originally placed into the body of the subject,and “distal” means further from this orifice.)

FIG. 2 shows delivery tool 20 in its assembled state comprisinglongitudinal members 60 and 62 which function as the repair chords thatare ultimately implanted in the heart of the patient. Respective firstend portions of longitudinal members 60 and 62 are coupled to a spoolthat is housed within a spool housing 42 of spool assembly 240. Thus,the implant structure comprises spool assembly 240 and longitudinalmembers 60 and 62. Each longitudinal member 60 and 62 has a free endthat is coupled to a respective suture needle 64. The pointed tips ofeach needle 64 are disposed within a respective slit 72 of a needleholder 70. Each longitudinal member 60 and 62 extends from its firstportions thereof, through a respective secondary lumen 192 of multilumenshaft 22 (as shown in the transverse cross-section of shaft 22) towardneedle holder 70. Needle holder 70 is shaped to provide knobs 170 forlooping portions of each longitudinal member 60 and 62 therearound.During delivery of spool assembly 240 to the implantation site in theventricle of the patient, portions of longitudinal members 60 and 62 arewound around knobs 170 of needle holder 70 and needles 64 are disposedwithin slits 72 of needle holder 70 so as to facilitate a traumaticdelivery of spool assembly 240 to the implantation site. During theimplantation of longitudinal members 60 and 62 in the heart of thepatient, needles 64 are extracted from slits 72, and longitudinalmembers 60 and 62 are unwound from knobs 170. Unwinding longitudinalmembers 60 and 62 extends longitudinal members 60 and 62 and providesthe operating physician with enough slack to suture respective portionsof longitudinal members 60 and 62 to heart tissue (e.g., a valve leafletor a portion of the ventricle wall) that faces and surrounds theventricular lumen of the heart.

Typically, longitudinal members 60 and 62 comprise a flexible and/orsuperelastic material, e.g., ePTFE, nitinol, PTFE, polyester, stainlesssteel, or cobalt chrome. In some embodiments, longitudinal members 60and 62 are coated with polytetrafluoroethylene (PTFE) or with PTFE. Insome embodiments, longitudinal members 60 and 62 comprise at least onewire/suture portion and at least one portion that comprises an elongatetensioning coil. For example, longitudinal members 60 and 62 maycomprise an elongate coil between two wire/suture portions.

Shaft 22 defines longitudinal slits 122 that run parallel with respectto a longitudinal axis of tool 20. Once longitudinal members 60 and 62are unwound from knobs 170, they are pulled from within lumens 192, viaslits 122, and away from the longitudinal axis of tool 20 in order torelease longitudinal members 60 and 62 from within shaft 22.

A distal portion of delivery tool 20 comprises a screwdriver housing 28which houses a screwdriver tool, as is described hereinbelow. Housing 28is shaped to define graspers 30 which reversibly grasp housing 42 ofadjusting mechanism 40 of spool assembly 240. Graspers 30 have atendency to compress toward one another, and thus are clamped aroundhousing 42. As shown in the enlarged distal portion of tool 22,longitudinal members 60 and 62 emerge from within housing 42. The spooldisposed within housing 42 is not shown for clarity of illustration;however, it is to be noted that respective portions of longitudinalmembers 60 and 62 are coupled to the spool. One or more (e.g., a pair,as shown) of guide wires 160 and 162 are (1) coupled at respective firstends thereof to housing 42 and extend (2) through respective proximalopenings 29 in screwdriver housing 28, (3) through respective secondarylumens 194 of multilumen shaft 22 (as shown in the transversecross-section of shaft 22), and (4) are coupled at respective secondends thereof to handle portion 24.

FIG. 3 shows a cross-sectional image of a distal portion of tool 20 andspool assembly 240 that is coupled to delivery tool 20 via graspers 30of screwdriver housing 28, in accordance with an embodiment of thepresent invention. Spool assembly 240 comprises an adjusting mechanism40 that is coupled to, e.g., welded to, a helical tissue anchor 50.Adjusting mechanism 40 comprises a housing 42 which houses a rotatablestructure, or a spool 46. Spool 46 has a cylindrical body that isdisposed in parallel with respect to the longitudinal axis of tool 20 byway of illustration and not limitation. Respective portions 63 oflongitudinal members 60 and 62 are coupled to (e.g., welded to, knottedto, looped within, or otherwise fastened to) spool 46 at coupling sites260 and 262, respectively.

Longitudinal members 60 and 62 extend externally to screwdriver housing28 and through respective secondary lumens 192 of multilumen shaft 22.It is to be noted that although two longitudinal members 60 and 62 areshown as being coupled to spool 46, any suitable number of longitudinalmembers may be coupled to spool 46. In some embodiments, only onelongitudinal member is coupled at a first end thereof to spool 46, andthe second end of the longitudinal member is configured to be attachedto heart tissue, e.g., a leaflet of an atrioventricular valve or aportion of the ventricular wall. For some applications, the onelongitudinal member may be looped within spool 46 in a manner in which amiddle portion thereof is looped within the spool and respectiveportions thereof extend from spool 46 along shaft 22 in their respectivelumens 192. In such an embodiment, the one longitudinal member definestwo free ends which are coupled to suture needles and are ultimatelyattached to, e.g., sutured to, heart tissue.

A distal end of shaft 22 is disposed proximally to a proximal end ofscrewdriver housing 28. As described hereinabove, torque-delivering-tool26 and overtube 90 that surrounds torque-delivering-tool 26 are disposedwithin primary lumen 190 of shaft 22. Screwdriver housing 28 is shapedto define a primary lumen which receives a distal portion oftorque-delivering-tool 26 and a distal portion of overtube 90. Duringdelivery of spool assembly 240 to the implantation site in theventricle, a distal end of overtube 90 is disposed within housing 28proximally to a distal end of torque-delivering-tool 26. A distalportion of torque-delivering-tool 26 is disposed within a screwdriverhead 95 that is disposed within housing 28. Screwdriver head 95 defineda recess for receiving the distal portion of torque-delivering-tool 26.Screwdriver head 95 is shaped to provide a spool-rotating portion 94which fits within a channel defined by spool 46. Spool-rotating portion94 is shaped in accordance with the shape of the channel defined byspool 46 such that rotation of torque-delivering-tool 26 delivers torqueto and rotates screwdriver head 95. In response to the rotation ofscrewdriver head 95, spool-rotating portion 94 pushes against the wallof spool 46 that defines the channel extending therethrough, andresponsively, spool 46 is rotated.

Reference is now made to FIGS. 2-3. As shown in FIG. 2, guide wires 160and 162 extend from spool housing 42 and through openings 29 defined inscrewdriver housing 28. Since guide wires 160 and 162 are disposedwithin lumens of multilumen shaft 22 that are orthogonal with respect tolumens 192 (which surround longitudinal members 60 and 62), guide wires160 and 162 are not shown in FIG. 3. Similarly, the openings 29 ofscrewdriver housing 28 are not shown in FIG. 3. It is to be noted thatscrewdriver housing is shaped to define a respective secondary lumenwhich surrounds each guide wire 160 and 162 and extend from spoolhousing 42 toward each proximal opening 29 in screwdriver housing 28.These secondary lumens run in parallel with respect to the primary lumendefined by housing 28 that surrounds torque-delivering-tool 26 andovertube 90.

FIG. 4A shows a relationship between individual components of adjustingmechanism 40, in accordance with an embodiment of the present invention.Adjusting mechanism 40 is shown as comprising spool housing 42 whichdefines an upper surface 41 and a recessed portion 142. Spool 46 isconfigured to be disposed within housing 42 and defines an upper surface150, a lower surface 152 and a cylindrical body portion disposedvertically between surfaces 150 and 152. Spool 46 is shaped to provide adriving interface, e.g., a channel 48, which extends from an openingprovided by upper surface 150 to an opening provided by lower surface152. Channel 48 of the driving interface is shaped to define a hexagonalchannel or a channel having another shape. The cylindrical body portionof spool 46 is shaped to define holes 260 and 262 which function asrespective coupling sites for coupling longitudinal members 60 and 62 tospool 46. In some embodiments, system 10 described herein comprises onlyone longitudinal member which is looped through spool 46 via holes 260and 262.

Coupling sites 260 and 262 may be shaped to define holes, as shown, orslits through which respective portions of longitudinal members 60 and62 are looped therethrough. In some embodiments, respective portions oflongitudinal members 60 and 62 are looped through coupling sites 260 and262 such that their ends are disposed within channel 48 of spool 46. Theends of longitudinal members 60 and 62 are knotted within channel 48 soas to fix the ends within channel 48 and prevent their release fromspool 46. In some embodiments, coupling sites 260 and 262 are shaped todefine male projections, e.g., knobs or hooks, around which respectiveportions of longitudinal members 60 and 62 are ensnared or looped andthereby coupled to spool 46.

Lower surface 152 of spool 46 is shaped to define one or more (e.g., aplurality, as shown) recesses 154 which define structural barrierportions 155 of lower surface 152. It is to be noted that any suitablenumber of recesses 154 may be provided, e.g., between 1 and 10 recesses,circumferentially with respect to lower surface 152 of spool 46.

A locking mechanism 45 is coupled to lower surface 152 and is coupled,e.g., welded, at least in part to a lower surface of spool housing 42.Typically, locking mechanism 45 defines a mechanical element having aplanar surface that defines slits 58. It is to be noted that the surfaceof locking mechanism 45 may also be curved, and not planar. Lockingmechanism 45 is shaped to provide a protrusion 156 which projects out ofa plane defined by the planar surface of the mechanical element. Slits58 define a depressible portion 128 of locking mechanism 45 that isdisposed in communication with and extends toward protrusion 156.Depressible portion 128 is moveable in response to a force appliedthereto typically by screwdriver head 95, as shown in detail hereinbelowwith reference to FIGS. 4B-C.

It is to be noted that the planar, mechanical element of lockingmechanism 45 is shown by way of illustration and not limitation and thatany suitable mechanical element having or lacking a planar surface butshaped to define at least one protrusion may be used together withlocking mechanism 45.

A cap 44 is provided that is shaped to define a planar surface and anannular wall having an upper surface 244 thereof. Upper surface 244 ofthe annular wall is coupled to, e.g., welded to, a lower surfaceprovided by spool housing 42. The annular wall of cap 44 is shaped todefine a recessed portion 144 of cap 44 that is in alignment withrecessed portion 142 of spool housing 42.

Reference is now made to FIGS. 4B-C which are schematic illustrations ofadjusting mechanism 40 in respective locking states thereof, inaccordance with an embodiment of the present invention. It is to benoted that longitudinal members 60 and 62 that are typically coupled tospool 46, are not shown for clarity of illustration. FIG. 4B showsadjusting mechanism 40 in an unlocked configuration in which protrusion156 of locking mechanism 45 is disposed within recessed portion 144 ofcap 44. FIG. 4C shows the locked state of spool 46 by the positioning ofprotrusion 156 within a recess 154 of spool 46.

Reference is now made to FIGS. 3 and 4B-C. FIG. 4B shows adjustingmechanism 40 in an unlocked state thereof, as shown in FIG. 3. During(1) the delivery of spool assembly 240 to the implantation site in afirst portion of tissue defining the ventricular lumen of the patient,(2) the attachment of the longitudinal members to a second portion ofheart tissue that faces surrounds the ventricular lumen of the patient,and (3) the subsequent rotation of spool 46 to adjust a length betweenthe first and second portions of heart tissue, adjusting mechanism 40 isdisposed in an unlocked state, as shown in FIGS. 3 and 4B. As shown inFIG. 4C, spool 46 is shaped to provide a first opening 180 at uppersurface 150 thereof and a second opening 182 at a lower surface 152thereof. Spool 46 defines a channel 48 that extends from first opening180 toward second opening 182.

FIGS. 3 and 4B show adjusting mechanism 40 in an unlocked state thereofin which screwdriver head 95 is disposed within channel 48 of spool 46.Screwdriver head 95 comprises an elongate body shaped to define aproximal generally cylindrical structure and spool-rotating portion 94which fits within channel 48 defined by spool 46. Spool-rotating portion94 is shaped to define a distal force applicator 93 which is disposedproximally to and in communication with depressible portion 128 oflocking mechanism 45. In the unlocked state of adjusting mechanism 40,screwdriver head 95 is disposed with respect to housing 42 in a mannerin which a distal end of force applicator 93 extends beyond secondopening 182 of spool 46 and pushes against depressible portion 128 oflocking mechanism 45. Depressible portion 128 is thus pushed downward,as shown.

Channel 48 of spool 46 is shaped to accommodate the dimensions ofspool-rotating portion 94 and force application 93 of screwdriver head95. Spool-rotating portion 94 has a width that is wider than the forceapplicator 93. In turn, channel 48 of spool 46 is shaped to accommodatespool-rotating portion 94 and force application 93 defining an upperportion and a lower portion thereof in which the upper portion ofchannel 48 is wider than the lower portion. The narrower lower portionof channel 48 ensures that force applicator 93 is not advanced distallybeyond a certain point as the narrower lower portion of channel 48restricts passage therethrough of the upper, wider portion ofspool-rotating portion 94. Screwdriver head 95 is shaped to define ashelf portion 91 which rests against upper surface 41 of spool housing42. Similarly, spool-rotating portion 94 is shaped to define a shelfportion 143 which rests against a horizontal wall of spool 46 whichdefines a portion of channel 48. During the unlocked state of adjustingmechanism 40, screwdriver head 95 is disposed in a manner in which shelfportion 91 thereof rests against upper surface 41 of spool housing 42,and shelf 143 of spool-rotating portion 94 rests against the horizontalwall of channel 48, as shown.

During the unlocked state of adjusting mechanism 40, depressible portion128 is maintained in a pushed state by force applicator 93. In such astate, protrusion 156 of locking mechanism 45 is maintained in a pushedstate toward the planar surface of cap 44. It is to be noted that thesurface of cap 44 may also be curved, and not planar. As describedhereinabove, cap 44 is shaped to provide a recessed portion 144 forreceiving protrusion 156 in its pushed-down state. As depressibleportion 128 is pushed downward, protrusion 156 is freed from within arecess 154 defined by structural barrier portions 155 of the lowerportion of spool 46. Additionally, protrusion 156 is freed from withinrecessed portion 142 provided by spool housing 42. Responsively,adjusting mechanism 40 is unlocked, and spool 46 may be rotated byscrewdriver head 95 in either clockwise or counter-clockwise directionsin response to torque delivered to head 95 by torque-delivering-tool 26coupled thereto. In response to the torque, spool-rotating portion 94 ofscrewdriver head 95 engages and pushes against the wall defining channel48 in order to rotate spool 46.

Cap 44 functions to restrict distal pushing of depressible portion 128beyond a desired distance so as to inhibit deformation of lockingmechanism 45. Once adjustment mechanism 40 is implanted in heart tissue,cap 44 also provides an interface between adjusting mechanism 40 and theheart tissue. This prevents interference of heart tissue on adjustingmechanism 40 during the locking and unlocking thereof. Additionally, cap44 prevents damage to heart tissue by depressible portion 128 as it ispushed downward.

FIG. 4C shows adjusting mechanism 40 in a locked state thereof in whichlocking mechanism 45 is shown in a resting state thereof. In the restingstate of locking mechanism 45, depressible portion 128 is disposed in ahorizontal position (i.e., perpendicularly with respect to alongitudinal axis of channel 48) in response to removal of screwdriverhead 95 from within channel 48 of spool 46. Depressible portion 128 hasa tendency to assume the horizontal position, as shown, and in theabsence of a downward pushing force applied to depressible portion 128by screwdriver head 95, depressible portion 128 returns to itshorizontal position from its pushed-down state, as shown in FIG. 4B. Inthis horizontal position, protrusion 156 of locking mechanism 45 isremoved from recessed portion 144 of cap 44 and is returned within arecess 154 of spool 46 and thereby restricts movement of spool 46 andlocks adjusting mechanism 40. Additionally, protrusion 156 of lockingmechanism 45 returns in part within recessed portion 142 of spoolhousing 42. Thus, recessed portion 142 of spool housing 42 providessupplemental locking of locking mechanism 45.

Reference is now made to FIGS. 5A-G, which are schematic illustrationsof a method for implantation of spool assembly 240 and longitudinalmembers 60 and 62 of system 10 in the heart of the patient, inaccordance with an embodiment of the present invention. FIG. 5A shows anopen heart procedure in which an operating physician positioning tool 20in a heart 2 of a patient and implanting spool assembly 240 in tissue ofa papillary muscle 4 of the left ventricle of heart 2. FIG. 5A shows thegeneral relative perspective of tool 20 with respect to heart 2. It isto be noted that FIGS. 5A-G are not drawn to scale in order toillustrate clearly the function of tool 20 in heart 2.

FIG. 5B shows a distal portion of tool 20 disposed within the leftventricle of heart 2. The operating physician advances a distal portion71 of tool 20 between leaflets 12 and 14 of a mitral valve 8. Tool 20 isdisposed with respect to heart 2 in a manner in which needle holder 70is disposed outside of heart 2. As shown in the enlarged portion ofneedle holder 70, needle 64 of longitudinal member 60 is disposed withinslit 72 of needle holder 70. Additionally, longitudinal member 60 islooped around knobs 170 of needle holder 70 such that knobs 170 gatherexcess portions of longitudinal member 60. Longitudinal member 60emerges from within slit 122 defined by multilumen shaft 22 at aproximal opening 61 of slit 122. Longitudinal member 62 is also shown asemerging from within its respective-slit in shaft 22. The needle coupledto longitudinal member 62 is also housed within a slit provided byneedle holder 70 (needle not shown for clarity of illustration).

Delivery tool 20 is rotated in order to corkscrew helical anchor 50spool assembly 240 into tissue of papillary muscle 4 at anintraventricular implantation site 5. Spool assembly 240 is coupled tocardiac tissue in a manner in which spool housing 42 and spool 46 aredisposed within the ventricular lumen at the intraventricularimplantation site. Tissue anchor 50 is corkscrewed into the cardiactissue in a manner in which it is disposed fully within the hearttissue, e.g., papillary muscle, endocardium, or myocardium, and does notextend beyond a pericardium of the heart. Papillary muscle 4 includes aportion of cardiac tissue which faces and surrounds the left ventricularlumen of heart 2. In response to rotation of tool 20, spool assembly 240is implanted at a first implantation site 5. In the enlarged view of thedistal portion of tool 20 and spool assembly 240, longitudinal members60 and 62 (coupled to spool 46) and guide wires 160 and 162 (coupled tohousing 42) are shown as emerging from housing 42 and are fed withintheir secondary respective lumens of multilumen shaft 22.

Guide wires 160 and 162 extend within their respective lumens 194 ofshaft 22 and toward handle 24. Handle 24 is shaped to provide a handlelumen 23 thereof, as shown in the enlarged longitudinal cross-sectionalimage of handle 24 (section A-A). A guide wire grasper 250 is disposedwithin lumen 23 and is coupled to the proximal ends of each guide wire160 and 162. Handle lumen 23 has a handle-lumen-length L1 of between 50mm and 100 mm, e.g., 70 mm. A proximal end 25 of multilumen shaft 22 isdisposed at a distal portion of lumen 23.

A proximal portion 241 of multilumen shaft 22 (i.e., the portion ofshaft 22 that is disposed immediately distal to proximal end 25 of shaft22) is configured to slide within lumen 23. Proximal portion 241 ofshaft 22 slides within lumen 23 when the operating physician graspsshaft 22 and slides shaft 22 proximally. Proximal portion 241 of shaft22 also has a shaft-length L2 such that proximal portion 241 fits withinhandle lumen 23, as is described hereinbelow. A guide 27 is coupled toproximal end 25 of shaft 22 and is advanced proximally within lumen 23in response to proximal sliding of portion 241 of shaft 22 within lumen23. Ultimately, in response to the sliding of proximal portion 241 ofshaft 22 within lumen 23 of handle 24, distal portion 71 of shaft 22slides proximally with respect to overtube 90 such that distal portion71 is disposed entirely within the left atrium of the patient, i.e., notwithin the left ventricle (as shown in FIG. 5D).

As shown, following the proximal sliding of shaft 22, needle holder 70is positioned proximally and adjacently to the distal end of handle 24.

Section B-B shows a transverse cross-section of delivery tool 22 at adistal portion of handle 24. Section B-B shows handle 24 which surroundsguide 27. Guide 27, in turn, surrounds a proximal end of multilumenshaft 22. Torque-delivering-tool 26 surrounded by overtube 90 aredisposed within the primary lumen of shaft 22. As shown, guide members160 and 162 are disposed within secondary lumens 194 of shaft 22.Secondary lumens 192 (which house longitudinal members 60 and 62 at theportion of tool between needle holder 70 and the distal end of shaft 22)are empty at handle 24 because longitudinal members 60 and 62 exitlumens 192 distally to needle holder 70.

As shown in Section A-A, handle 24 comprises a torque facilitator (e.g.,a spring) 132 that is coupled to and surrounds a proximal portion oftorque-delivering-tool 26. Torque-delivering-tool 26 extends proximallywithin handle 24 to rotating structure 32 at the proximal end of handle24.

FIG. 5C shows the extracting of longitudinal members 60 and 62 fromwithin their respective lumens 192 of shaft 22. Needles 64 are pulledfrom within slits 72 of needle holder 70. Then, longitudinal members 60and 62 are unwound from knobs 170 of needle holder 70 and pulled awayfrom the longitudinal axis of shaft 22 along slits 122 of shaft 22.Following the extracting of longitudinal members 60 and 62 from theirrespective lumens 192, needles 64 are held outside heart 2 so as not topuncture tissue of the heart. The free ends of longitudinal members 60and 62, which are coupled to needles 64 are then sutured to leaflet 12at a second implantation site 7 at a portion of heart tissue which facesand surrounds the ventricular lumen of heart 2.

FIG. 5D shows longitudinal members 60 and 62 coupled to leaflet 12 atsecond implantation site 7. Longitudinal members 60 and 62 are knottedtogether using suture knots 67, and excess portions of longitudinalmembers 60 and 62 are cut away from knot 67. It is to be noted thatalthough knot 67 is used to couple longitudinal members 60 and 62 toleaflet 12, any suitable anchor may be used. For example, longitudinalmember 60 may comprise a male clip at its free end and longitudinalmember 62 may comprise a female clip at its free end. In such anembodiment, longitudinal members 60 and 62 are clipped at their freeends to leaflet 12.

Following the coupling of longitudinal members 60 and 62 to leaflet 12,shaft 22 is slid proximally to expose a portion of overtube 90 andtorque-delivering-tool 26. During the proximal sliding of shaft 22,proximal portion 241 of shaft 22 is slid within lumen 23 of handle 24.Handle-lumen-length L1 of lumen 23 of handle 24 is long enough toaccommodate shaft-length L2 of proximal portion 241 of shaft 22. Inresponse to the sliding of shaft 22, the distal portion of the exposedovertube 90 and torque-delivering-tool 26 defines atorque-delivering-tool-length L3 at a distal portion thereof that isequal to shaft-length L2 of proximal portion 241 of shaft 22. Thus,handle-lumen-length L1, shaft-length L2 at proximal portion 241 of shaft22, and torque-delivering-tool-length L3 at the distal portion thereofare equal and have a ratio of between 0.7:1 and 1.3:1.

Shaft-length L2 of proximal portion 241 of shaft 22 is such that whenportion 241 slides within lumen 23 of handle 24 as shaft 22 is slidproximally along overtube 90, a distal-most end 65 of shaft 22 isdisposed proximally to mitral valve 8 (i.e. distal-most end 65 of shaft22 is disposed in the left atrium of heart 2). Typically, multilumenshaft 22 has a diameter of between 1.5 mm and 4 mm, typically, 3 mm, andovertube 90 has a diameter of between 0.8 mm and 1.5 mm, typically, 1.5mm. Sliding of shaft 22 to position distal-most end 65 of shaft 22 inthe left atrium, thus reduces the diameter of tool 20 between leaflets12 and 14 of valve 8.

Following the sliding, the incision is closed around tool 20 using apurse string stitch, for example. The patient is removed from thecardiopulmonary bypass pump and heart 2 is allowed to resume its normalfunction. While heart 2 is beating, spool 46 of adjustment mechanism 40may then be rotated in order to adjust a length of longitudinal members60 and 62, and responsively, a distance between first and secondimplantation sites 5 and 7 is adjusted. The adjustment of longitudinalmembers is typically performed with the aid of imaging, such asfluoroscopy, transesophageal echo, and/or echocardiography.

Sliding of shaft 22 thus reduces the diameter of the portion of tool 20that is disposed between leaflets 12 and 14, and thus, reducesinterference of tool 20 on the beating of valve 8 as longitudinalmembers 60 and 62 are adjusted.

Reference is now made to FIGS. 3 and 5E. FIG. 5E shows the adjustment oflongitudinal members 60 and 62 by adjusting mechanism 40 and deliverytool 20. During the adjustment of longitudinal members 60 and 62,locking mechanism 45 of adjustment mechanism 40 is disposed in anunlocked state with respect to spool 46 (as shown in FIG. 3). Rotatingstructure 32 is rotated in a first direction thereof, as indicated byarrow A. In response to the rotation of structure 32,torque-delivering-tool 26 is rotated. Responsively, screwdriver head 95that is coupled to the distal end of torque-delivering-tool 26 isrotated and spool-rotating portion 94 pushes against the wall definingchannel 48 of spool 46. Such pushing applies an annular force to thespool which facilitates rotation of spool 46 in a first directionthereof.

In response to the rotation of spool 46 in the first direction, asindicated by arrow A, respective first portions of longitudinal members60 and 62 are wrapped around spool 46, as shown in the enlargedcross-sectional image of adjusting mechanism 40. As longitudinal members60 and 62 are wrapped around spool 46, respective second portions ofmembers 60 and 62 (i.e., the portions which are coupled to secondimplantation site 7) are pulled toward adjusting mechanism 40 implantedat first implantation site 5. This draws the second portions oflongitudinal member 60 and 62 and leaflet 12 toward the first portionsof longitudinal members 60 and 62 that are wrapped around spool 46.Responsively, the respective lengths of longitudinal members 60 and 62between the second portions thereof and spool 46 are shortened andlongitudinal members 60 and 62 are tightened.

Since spool 46 is unlocked (as shown in FIG. 3), spool 46 may be rotatedin a second direction that is opposite the direction used to tightenlongitudinal members 60 and 62 (i.e., in the direction that is oppositethat which is indicated by arrow A in FIG. 5E). Rotating spool 46 in thesecond direction unwinds longitudinal members 60 and 62 from aroundspool 46 and thereby elongates the portions of longitudinal members 60and 62 between first and second implantation sites 5 and 7.

Overtube 90 comprises a tube which surrounds torque-delivering-tool 26.Since shaft 22 is retracted proximally (as shown) during the adjustmentof longitudinal members 60 and 62, overtube 90 functions to providerigidity and stability to torque-delivering-tool 26 as it deliverstorque to spool 46. Overtube 90 comprises a flexible material, e.g.,polyamide, ePTFE, or PTFE. In some embodiments, the material of overtube90 is braided. For some applications, overtube 90 is coated with PTFE.

As shown in FIG. 5E, longitudinal members 60 and 62 are pulled tightfrom their relaxed state (shown in FIG. 5D) in response to rotationfacilitated by adjusting mechanism 40. Longitudinal members 60 and 62are pulled until they resemble native chordae tendineae 6, and thuslongitudinal members 60 and 62 function to replace the defective andstretched native chordae tendineae and restore normal functionality toheart valve 8.

Reference is again made to FIGS. 3 and 5E. FIG. 3 shows screwdriver head95 being shaped to provide a horizontal shelf portion 91 which restsagainst upper surface 41 of spool housing 42. Similarly, spool-rotatingportion 94 is shaped to define a shelf portion 143 which rests against ahorizontal wall of spool 46 which defines a portion of channel 48.During the unlocked state of adjusting mechanism 40 (as shown in FIG.3), screwdriver head 95 is disposed in a manner in which shelf portion91 thereof rests against upper surface 41 of spool housing 42, and shelf143 of spool-rotating portion 94 rests against the horizontal wall ofchannel 48, as shown.

Following the adjustment of the respective lengths of longitudinalmembers 60 and 62, delivery tool 20 is decoupled from spool assembly240. The operating physician pushes on rotating structure 32, in thedirection as indicated by arrow B in FIG. 5E. The proximal portion ofhandle 24 is shaped to define a recessed portion for receiving a distalportion of rotating structure 32 in response to the pushing thereof.Pushing on rotating structure 32 thereby pushes torque-delivering-tool26 coupled thereto. Responsively, screwdriver head 95 that is coupled totorque-delivering-tool 26 is pushed distally. As screwdriver head 95 ispushed, shelf portion 91 pushes against upper surface 41 of housing 42in order to facilitate pulling of tool 20 away from spool assembly 240.Responsively, screwdriver head 95 and graspers 30 are distanced fromhousing 42, as shown in the enlarged cross-sectional image of adjustmentmechanism 40.

Graspers 30 are resiliently biased to angle inward and surround thecurved outer wall of housing 42. Following the pushing of shelf portion91 of screwdriver head 95 against upper surface 41 of housing 42, tool20 is pulled proximally in the direction as indicated by arrow C in theenlarged image of spool assembly 240 and the distal portion of tool 20.During the pulling proximally of tool 240, the curved wall of housing 42pushes against resilient graspers 30 in order to radially push graspers30. Such pushing radially of graspers 30 helps further decouple tool 20from spool assembly 240.

During the decoupling of tool 20 from spool assembly 46, spool-rotatingportion 94 and distal force applicator 93 of screwdriver head 95 arepulled proximally such that the distal end of force applicator 93 isdisposed proximally to and does not apply a pushing force to depressibleportion 128 of locking mechanism 45. In the absence of the downwardpushing force by screwdriver head 95, depressible portion 128 returns toits resting state, i.e., perpendicular with respect to the longitudinalaxis of channel 48. As depressible portion 128 returns to its restingstate, protrusion 156 is introduced within one of the plurality ofrecesses 154 of lower surface 152 of spool 46 and thereby locks andrestricts rotation of spool 46.

FIG. 5F shows delivery tool 20 being pulled away from heart 2 andultimately outside of the body of the patient. Delivery tool 20 slidesalong guide wires 160 and 162 which pass through openings 29 inscrewdriver housing 28 of tool 20. Guide wires 160 and 162 are leftpartially within heart 2 and provide an access to implantation site 5.Sliding of tool 20 along guide wires 160 and 162 frees heart 2 of anytool.

Once free of tool 20, the operating physician may then repair any otherdefect in the heart without any obstruction and interference by tool 20.In some cases, the operating physician introduces a second spoolassembly 240 into another implantation site in the left ventricle andrepairs another portion of heart 2. In some embodiments, the secondspool assembly is implanted in a second papillary muscle of theventricle and the longitudinal member(s) coupled thereto are coupled attheir free ends to either leaflet 12 or 14. The longitudinal member(s)then function as secondary artificial chordae tendineae.

In some embodiments, the second spool assembly 240 is coupled to a firstportion of the ventricle wall (i.e., and not to the papillary muscle) atthe base of the papillary muscle, or at another portion of the ventriclewall which faces and surrounds the ventricular lumen of heart 2. In someembodiments, the free ends of the longitudinal member(s) coupled to thesecond spool assembly are coupled to either leaflet 12 or 14 (as shownhereinbelow with reference to FIG. 8). Alternatively, the free ends ofthe longitudinal member(s) are coupled to a second portion of theventricle wall (as shown hereinbelow with reference to FIGS. 10A-B) inorder to draw the first and second portions the ventricle wall towardeach other.

In either embodiment, guide wires 160 and 162 remain coupled to housing42 during and following the initial procedure including the implantationof spool assembly and adjustment of longitudinal members 60 and 62.Guide wires 160 and 162 enable the operating physician to accessimplantation site 5 at any time during and after the initial procedure.During the initial implantation procedure delivery tool 20 may remaincoupled to guide wires 160 and 162 and slide in and out of heart 2. Thephysician is able to slide tool 20 toward spool assembly 240 andfacilitate supplemental rotation of spool 46 and adjustment oflongitudinal members 60 and 62. Following the adjustment, tool 20 isslid out of heart 2 and is decoupled from guide wires 160 and 162.

FIG. 5G shows a multilumen guide tube 300 coupled at a distal endthereof to spool assembly 240. Guide tube 300 defines a primary lumen302 and respective secondary lumens 304 which surround guide wires 160and 162. Following the removal of tool 20, guide tube 300 is advancedtoward implantation site 5 along guide wires 160 and 162. Guide tube 300is advanced along guide wires 160 and 162 through an opening 330 inheart 2, and ultimately toward implantation site 5. A distal end ofguide tube 300 is coupled to spool housing 42 of spool assembly 240, anda proximal end of guide tube 300 is coupled to a portion of subcutaneoustissue of the patient. A port 320 is coupled to a proximal end of guidetube 300 and is implanted subcutaneously beneath skin 310 of the patienttypically in the vicinity of the ribcage. Port 320 projects slightlyunder skin 310 to create a bump 312.

FIG. 6 is a schematic illustration of extracardiac apparatus comprisingtorque-delivering-tool 26 accessing spool assembly 240 via port 320, inaccordance with an embodiment of the present invention. The physicianfeels for bump 312 of skin 310 and creates a small incision in thetissue in order to access port 320. Torque-delivering-tool 26 isadvanced through primary lumen 302 of guide tube 300 (as shown in thetransverse cross-sectional image of guide tube 300) and accessesadjusting mechanism 40 of spool assembly 240 from a site outside thebody of the patient.

The operating physician may access spool assembly 240 via port 320, at alater stage following initial implantation of assembly 240 in order toreadjust longitudinal members 60 and 62. For example, in the event thatlongitudinal members 60 and 62 are loosened (as shown) and need to betightened, spool assembly 240 may be accessed in order to tightenlongitudinal members 60 and 62.

Torque-delivering-tool 26 is coupled at a distal end thereof toscrewdriver head 95. Screwdriver head 95 accesses spool 46 of adjustmentmechanism 40 and rotates spool 46 (in a manner as described hereinabove)in order to adjust longitudinal members 60 and 62. The readjustmentprocedure is typically performed with the aid of imaging, such asfluoroscopy, transesophageal echo, and/or echocardiography.

Reference is now made to FIG. 7, which is a schematic illustration of asystem 400 for implanting spool assembly 240 and adjusting longitudinalmembers 60 and 62, as described hereinabove with reference to FIGS.5A-G, with the exception that guide wires 160 and 162 do not remainpartially disposed within heart 2, in accordance with an embodiment ofthe present invention. In such an embodiment, guide wires 160 and 162are used only during the initial implantation of spool assembly 240 andadjustment of longitudinal members 60 and 62. Guide wires 160 and 162 inthis embodiment, facilitate the removal of tool 20 from heart 2 and thereplacement of tool 20 in heart 2 during the initial procedure.

FIG. 8 is a schematic illustration of a system 500 for implanting spoolassembly 240 and adjusting longitudinal members 60 and 62, as describedhereinabove with reference to FIGS. 5A-G, with the exception that spoolassembly is implanted in a portion 200 of the heart wall of theventricle, in accordance with an embodiment of the present invention.Portion 200 of the heart wall includes a portion of the wall which facesand surrounds the ventricular lumen of heart 2.

Tissue anchor 50 is corkscrewed into the cardiac tissue in a manner inwhich it is disposed fully within portion 200 of the heart tissue, e.g.,endocardium or myocardium, and does not extend beyond a pericardium 202of heart 2.

Reference is now made to FIGS. 9, 10A-B, and 11 which are schematicillustrations of respective systems for repairing malpositioning of thewall of the ventricle of the patient, in accordance with respectiveembodiments of the present invention. FIG. 9 is a schematic illustrationof heart 2 in a weakened state in which the wall of the left ventricleis malpositioned and weakened. As a result, leaflets 12 and 14 of mitralvalve 8 are malpositioned and are distanced from each other.

FIG. 10A shows system 600 comprising spool assembly 240 implanted at afirst portion 420 of heart tissue which faces and surrounds the leftventricle of heart 2. First implantation site 5 thus comprises firstportion 420 of heart tissue. Spool assembly 240 is implanted via tool 20at site 5 in a manner as described hereinabove with reference to FIGS.5A-G. The free ends of longitudinal members 60 and 62 are coupled to asecond portion 422 of heart tissue which faces and surrounds the leftventricle of heart 2. Second implantation site 7 thus comprises secondportion 422 of heart tissue, e.g., at the septum, by way of illustrationand not limitation. The free ends of longitudinal members 60 and 62 arecoupled to the heart tissue using any suitable attachment means 602,e.g., sutures, knotting, or tissue anchors such as helical anchors.Spool 46 of adjustment mechanism 40 is rotated by tool 20, as describedhereinabove, thereby pulling tight longitudinal members 60 and 62 andthereby reducing a length of longitudinal members 60 and 62 betweenfirst and second implantation sites 5 and 7. In response to the pullingof longitudinal members 60 and 62, first and second portions 420 and 422of the heart tissue are pulled toward each other. Consequently, thedimensions of the heart wall are restored to physiological dimensions,and leaflets 12 and 14 are drawn toward each other.

FIG. 10B shows system 700 for adjusting a distance between two portionsof a heart wall of the left ventricle of the patient. Longitudinalmembers 60 and 62 are coupled at first portions thereof to spool 46 ofadjustment mechanism 40. Respective free ends of each member 60 and 62are coupled to opposing first and second portions of the heart wallwhich faces and surrounds the ventricular lumen of heart 2. The free endof longitudinal member 62 is coupled to first implantation site 5 usinga first helical anchor 750 by way of illustration and not limitation.For example, the free end of longitudinal member 62 is coupled to firstimplantation site 5 using sutures, knots, or any tissue anchor known inthe art. The free end of longitudinal member 60 is coupled to secondimplantation site 7 using a second helical anchor 750 by way ofillustration and not limitation. For example, the free end oflongitudinal member 60 is coupled to second implantation site 7 usingsutures, knots, or any tissue anchor known in the art. In such aconfiguration, adjustment mechanism 40 is disposed between longitudinalmembers 60 and 62 and is not directly coupled to heart tissue.

Following the attaching of longitudinal members 60 and 62 toimplantation sites 5 and 7, respectively, spool 46 of adjustmentmechanism 40 may be rotated using tool 20, in a manner as describedhereinabove. As described hereinabove, using tool 20, spool 46 ofadjustment mechanism 40 is rotated in order to adjust a distance betweenfirst and second implantation sites 5 and 7. Responsively, the first andsecond portions of the ventricle wall are drawn together. Consequently,the dimensions of the heart wall are restored to physiologicaldimensions, and leaflets 12 and 14 are drawn toward each other.

FIG. 11 is a schematic illustration of a system 800 for adjusting adistance between two portions of a heart wall of the left ventricle ofthe patient. System 800 comprises a tensioning device 802 coupled at afirst end thereof to spool assembly 240. In a manner as describedhereinabove, using tool 20, spool assembly 240 is implanted at firstimplantation site 5 in a first portion of tissue of the heart wall thatfaces and surrounds the ventricular lumen. The free end, i.e., secondportion, of tensioning device 802 is attached at second implantationsite 7 to a second portion of tissue of the heart wall that faces andsurrounds the ventricular lumen. The free end of tensioning device 802is implanted in heart tissue using a helical anchor by way ofillustration and not limitation. For example, the free end of tensioningdevice 802 may be coupled to second implantation site 7 using sutures,knots, or any tissue anchor known in the art.

Tensioning device 802 comprises a flexible material, e.g., ePTFE ornitinol, and is shaped to define a coiled portion 806 that has a lengthof between 20 mm and 50 mm and a diameter of between 0.5 mm and 3.0 mm.Tensioning device 802 comprises wire/suture portions 804 on either sideof coiled portion 806.

As described hereinabove, using tool 20, spool 46 of adjustmentmechanism 40 is rotated in order to adjust a distance between first andsecond implantation sites 5 and 7. As spool 46 is rotated in a firstdirection thereof, suture portion 804 that is disposed adjacently tospool assembly 240 is wrapped around spool 46. Tensioning device 802 istightened and shortened in response to the wrapping of portion 804around spool 46. As device 802 is tightened, a force is applied tocoiled portion 806 of tensioning device 802. Coiled portion 806 appliesa supplemental pulling force to help pull the opposing first and secondportions of the ventricle wall toward each other. Consequently, thedimensions of the heart wall are restored to physiological dimensions,and leaflets 12 and 14 are drawn toward each other.

Reference is again made to FIGS. 9-11. It is to be noted that the scopeof the present invention includes the use of systems 600, 700, and 800for adjusting a distance between any two portions of the heart and notjust opposing portions, as described hereinabove. For example, first andsecond implantation sites 5 and 7 may be on the same side, e.g., theseptum, of the wall of the heart.

Reference is now made to FIGS. 12A-B which are schematic illustrationsof a system 900 for drawing together leaflets 12 and 14 of a mitralvalve of the patient, in accordance with an embodiment of the presentinvention. Spool assembly 240 is implanted in first implantation site 5at papillary muscle 4 of the left ventricle by way of illustration andnot limitation. For example, spool assembly 240 may be implanted in aportion of the heart wall of the ventricle, e.g., the base of thepapillary muscle. As described hereinabove respective first portions ofeach longitudinal member 60 and 62 are coupled to spool 46 of adjustmentmechanism 40. The free end, i.e., second portion, of longitudinal member60 is coupled, e.g., sutured, anchored, clipped, locked in place with acrimping bead, to leaflet 12 at an implantation site 902. The free end,i.e., second portion, of longitudinal member 62 is coupled, e.g.,sutured, anchored, clipped, locked in place with a crimping bead, toleaflet 14 at an implantation site 904.

As described hereinabove, using tool 20, spool 46 of adjustmentmechanism 40 is rotated in order to adjust a length of longitudinalmembers 60 and 62. As shown in FIG. 12B, longitudinal members 60 and 62are pulled tight in response to rotation of spool 46 in a firstdirection thereof. In response to the pulling of longitudinal members 60and 62 leaflets 12 and 14 are pulled toward each other in order torestore coaptation to valve 8.

It is to be noted that system 900 may be used on the tricuspid valve.

In some embodiments, spool assembly 240 is coupled to first implantationsite, e.g., papillary muscle 4, to the base of the papillary muscle, orto any suitable portion of heart tissue facing and surrounding theventricle. In such an embodiment:

(1) the free end of longitudinal member 60 is coupled to, e.g., suturedto or anchored to, a second implantation site (e.g., another portion ofthe inner wall of the heart that faces and surrounds the ventricle),

(2) the free end of longitudinal member 62 is coupled to, e.g., suturedto or anchored to, a third implantation site (e.g., yet another portionof the inner wall of the heart that opposes the portion of tissue towhich the free end of longitudinal member 60 is coupled), and

(3) rotation of spool 46 draws the first, second, and third implantationsites toward each other.

In some embodiments, system 900 may be used to provide adjustableartificial chordae tendineae as well as draw together portions of theinner wall of the ventricle, i.e., the portion of the heart tissue whichsurrounds and faces the ventricular lumen. In such an embodiment,longitudinal member 60 is coupled at a first end thereof to spool 46 andat a second end thereof to a leaflet of the atrioventricular valve.Longitudinal member 62 is coupled at a first end thereof to spool 46 andat a second end thereof to a portion of tissue of the inner wall of theventricle. As described hereinabove, spool assembly 240 is implanted atfirst implantation site 5 (e.g., papillary muscle 4, as shown, or anyother suitable portion of tissue of the inner wall of the ventricle). Inresponse to rotation of spool 46 of adjustment mechanism, both theleaflet and the portion of tissue of the inner wall of the ventricle arepulled toward spool assembly 240 at implantation site 5.

Reference is now made to FIGS. 1-12A-B. It is to be noted that theshortening of longitudinal members 60 and 62 described herein isreversible. That is, rotating spool 46 in a rotational direction thatopposes the rotational direction used to shorten the longitudinalmembers, unwinds respective portions of the longitudinal members fromaround spool 46. Unwinding the portion of the longitudinal members fromaround spool 46 thus slackens the remaining portions of the longitudinalmembers that are disposed between first and second implantation sites 5and 7. Responsively, the longitudinal members are elongated (i.e., withrespect to their shortened states state prior to the unwinding).

Reference is yet again made to FIGS. 1-12A-B. It is to be noted thatfollowing initial adjustment of the repair chords, the repair chords maybe further adjusted at a later state following the initial implantationthereof. Using real-time monitoring, tactile feedback and optionally incombination with fluoroscopic imaging, tool 20 may be reintroducedwithin the heart and engage spool 46.

It is to be noted that systems 10, 400, 500, and 900 may be used asartificial chordae tendineae to replace stretched native chordaetendineae of a left ventricle or of a right ventricle. For someapplications, spool assembly 240 is coupled to the papillary muscle. Forsuch applications, spool assembly 240 is coupled to a portion of thewall of the ventricular lumen.

It is to be noted that systems 600, 700, and 800 may be may be used inorder to repair malposition of portions of the wall of a left ventricleor of a right ventricle.

Reference is still yet again made to FIGS. 1-12A-B. It is to be notedthat first implantation site 5 may be any portion of tissue that facesand surrounds the ventricle of the heart of the patient. For example,first implantation site 5 may include a first portion of tissue of aninner wall of the ventricle at the base of the papillary muscle or anyother suitable location along the inner wall. First implantation site 5may also include tissue of the papillary muscle. It is to be noted thatsecond implantation site 7 may be any portion of tissue that faces andsurrounds the ventricle of the heart of the patient. For example, secondimplantation site 7 may include a second portion of tissue of an innerwall of the ventricle at the septum, or any other suitable locationalong the inner wall. Second implantation site 7 may also include aleaflet of an atrioventricular valve of the heart of the patient.

Reference is still yet again made to FIGS. 1-12A-B. It is to be notedthat systems described herein may be used to repair the heart duringopen-heart, minimally-invasive, and transcatheter procedures. Forembodiments in which delivery tool 20 is introduced within the heartduring minimally-invasive and transcatheter procedures, shaft 22,torque-delivering-tool 26, and overtube 90 are longer than as shownhereinabove. For such applications, suture needle 64 coupled to thelongitudinal member is coupled to needle holder 70 of tool 20 in amanner in which needle 64 faces outward. In such a configuration, thepiercing portion, e.g., a barbed portion, of needle 64 is exposed fromslit 72 of holder 70. In such an embodiment, needle holder 70 may becoupled to a distal portion of shaft 22.

For transcatheter procedures, delivery tool 20 is advanced toward theheart through an advancement catheter, e.g., a 12-13 F catheter. Theadvancement catheter facilitates a traumatic advancement of tool 20through vasculature of the patient by providing an overtube which coversthe outwardly-facing needle 64 of tool 20.

The advancement catheter is positioned in the heart in a manner in whicha distal end thereof is disposed within the ventricle of the patient anda portion of the advancement catheter extends between the leaflets ofthe atrioventricular valve of the patient. Tool 20 is advanced throughthe advancement catheter until a distal end thereof is disposed in thevicinity of first implantation site 5 and subsequently facilitates theimplantation of spool assembly 240 in tissue of the ventricle at firstimplantation site 5. Following the implantation of spool assembly 240 infirst implantation site 5, the advancement catheter and multilumen shaft22 are retracted proximally such that the distal-most ends of theadvancement catheter and shaft 22 are disposed proximally to theatrioventricular valve. The advancement catheter is retracted further inorder to expose the outwardly-facing needle 64 from within theadvancement catheter. Delivery tool 20 is then manipulated, e.g., pushedlaterally, such that the piercing portion, e.g., the barbed portion, ofneedle 64 is disposed adjacently to and punctures a leaflet of theatrioventricular valve. The barbed portion remains disposed coupled tothe leaflet, and thereby the second portion of the longitudinal memberis coupled to the leaflet.

Spool assembly 240 is then adjusted in a manner as described hereinabovein order to adjust a distance between the second portion of thelongitudinal member and spool assembly 240, and thereby create anadjustable artificial chordae tendineae that resembles the nativechordae tendineae. Following the adjusting of the longitudinal member,delivery tool 20 is decoupled from spool assembly 240, as describedhereinabove, and tool 20 and the advancement catheter are extracted fromwithin the body of the patient.

Reference is still yet again made to FIGS. 1-12A-B. It is to be notedthat spool housing 42 and spool 46 may be implanted in a first portionof tissue of the heart independently of tool 20 and tissue anchor 50. Insuch an embodiment, spool housing 42 is sutured to tissue of theventricle. Prior to implantation of housing 42, a longitudinal member iscoupled to, e.g., knotted to, welded to, looped through, spool 46 at afirst portion thereof. The second portion of spool 46 is coupled to,e.g., knotted to, sutured to, or anchored to, a second portion of tissueof the heart. Spool 46 may be rotated using any suitable screwdriver orscrewdriver head 95, as described hereinabove.

Reference is still yet again made to FIGS. 1-12A-B. Spool 46 may becoupled to the heart tissue in a manner in which a central longitudinalaxis through spool 46 forms an angle with a surface of the heart tissueof between about 30 and 180 degrees, e.g., between about 75 and 90degrees, such as about 90 degrees. In some embodiments, spool 46 iscoupled to the heart tissue in a manner in which the centrallongitudinal axis is parallel with the surface of the heart tissue.

For some applications, techniques described herein are practiced incombination with techniques described in one or more of the referencescited in the Background section and Cross-references section of thepresent patent application.

Additionally, the scope of the present invention includes embodimentsdescribed in one or more of the following:

-   PCT Publication WO 06/097931 to Gross et al., entitled, “Mitral    Valve treatment techniques,” filed Mar. 15, 2006;-   U.S. Provisional Patent Application 60/873,075 to Gross et al.,    entitled, “Mitral valve closure techniques,” filed Dec. 5, 2006;-   U.S. Provisional Patent Application 60/902,146 to Gross et al.,    entitled, “Mitral valve closure techniques,” filed on Feb. 16, 2007;-   U.S. Provisional Patent Application 61/001,013 to Gross et al.,    entitled, “Segmented ring placement,” filed Oct. 29, 2007;-   PCT Patent Application PCT/IL07/001,503 to Gross et al., entitled,    “Segmented ring placement,” filed on Dec. 5, 2007, which published    as WO 08/068,756;-   U.S. Provisional Patent Application 61/132,295 to Gross et al.,    entitled, “Annuloplasty devices and methods of delivery therefor,”    filed on Jun. 16, 2008;-   U.S. patent application Ser. No. 12/341,960 to Cabiri, entitled,    “Adjustable partial annuloplasty ring and mechanism therefor,” filed    on Dec. 22, 2008, which published as US 2010/0161047;-   U.S. Provisional Patent Application 61/207,908, to Miller et al.,    entitled, “Actively-engageable movement-restriction mechanism for    use with an annuloplasty structure,” filed on Feb. 17, 2009;-   A US patent application entitled “Annuloplasty ring with intra-ring    anchoring”;-   U.S. Pat. No. 7,431,692 to Zollinger et al.; and-   U.S. Patent Application Publication 2007/0118151 to Davidson.

All of these applications are incorporated herein by reference.Techniques described herein can be practiced in combination withtechniques described in one or more of these applications.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. Apparatus, comprising: a delivery toolcomprising: a handle portion defining a handle lumen; and a shaft (a)being slidable with respect to the handle portion, and (b) having aproximal portion thereof being slidable into the handle lumen duringproximal sliding of the shaft; a spool reversibly couplable to a distalend of the delivery tool and configured to be positioned in anintraventricular site of a ventricle of a patient, wherein: the spoolhas a first end shaped to define a first opening, and a second endshaped to define a second opening, the spool being shaped to define achannel extending from the first opening to the second opening, thechannel being configured for passage therethrough of an elongaterotation tool, and the second end of the spool has a lower surfacethereof shaped to define one or more recesses at locations along acircumference; and at least one longitudinal member having oppositefirst and second end portions, the first end portion being coupled tothe spool and the second end portion configured to be coupled to a firstportion of heart tissue that surrounds a ventricular space of theventricle of the patient, the longitudinal member: configured to bewound around the spool in response to rotation of the spool in a firstdirection thereof, and, responsively, to draw the second end portion ofthe longitudinal member and the first portion of heart tissue toward thefirst end portion of the longitudinal member.
 2. The apparatus accordingto claim 1, wherein the shaft is shaped to provide at least one shaftlumen configured for housing a section of the longitudinal member thatis between the first and second end portions thereof.
 3. The apparatusaccording to claim 1, wherein the longitudinal member comprises expandedpolytetrafluoroethylene (ePTFE).
 4. The apparatus according to claim 1,wherein at least a portion of the longitudinal member is shaped todefine a coil, and wherein the coil is configured to apply a tensioningforce to the first portion of heart tissue.
 5. The apparatus accordingto claim 1, wherein the longitudinal member is coated withpolytetrafluoroethylene.
 6. The apparatus according to claim 1, furthercomprising a locking mechanism coupled to the spool and configured torestrict rotation of the spool.
 7. The apparatus according to claim 1,further comprising at least one guide wire coupled to the spool, andwherein, subsequently to the positioning of the spool, the delivery toolis configured to be: decoupled from the spool and removed from theventricle, and advanceable along the guide wire.
 8. The apparatusaccording to claim 7, wherein the spool is configured to be implanted atthe intraventricular site, and wherein the guide wire is configured tofacilitate access of a torque-delivering-tool to the spool following theimplantation of the spool at the intraventricular site.
 9. The apparatusaccording to claim 1, further comprising a torque-delivering-tool,wherein: the shaft is shaped to define at least a primary shaft lumen,the torque-delivering-tool is coupled at a proximal end thereof to thehandle portion and is disposed in the primary shaft lumen, and the shaftis slidable with respect to the torque-delivering-tool.
 10. Theapparatus according to claim 9, wherein the delivery tool is configuredto be advanceable between leaflets of an atrioventricular valve of thepatient, and wherein the shaft is slidable with respect to thetorque-delivering-tool in a manner that reduces a diameter of a portionof the delivery tool that is disposed between the leaflets of the valve.11. The apparatus according to claim 9, wherein the handle lumen has ahandle-lumen-length of between 50 mm and 100 mm, and wherein the shaftis slidable in a proximal direction to advance the proximal portionthereof into the handle lumen.
 12. The apparatus according to claim 11,wherein a distal portion of the torque-delivering-tool is configured tobe positioned within the ventricular space of the heart and defines atorque-delivering-tool-length at the distal portion of between 50 mm and100 mm, and wherein a ratio of the handle-lumen-length and thetorque-delivering-tool-length at the distal portion is between 0.7:1 and1.3:1.
 13. The apparatus according to claim 1, wherein: the firstportion of heart tissue includes an atrioventricular valve having atleast first and second leaflets thereof, the at least one longitudinalmember comprises at least first and second longitudinal member portionshaving respective first and second end portions thereof, the first endportions of the first and second longitudinal member portions arecoupled to the spool, the second end portion of the first longitudinalmember portion is configured to be coupled to the first leaflet of thevalve, the second end portion of the second longitudinal member portionis configured to be coupled to the second leaflet of the valve, and inresponse to rotation of the spool, the first and second longitudinalmember portions are tightened and pull on the respective second endportions thereof toward the spool.
 14. The apparatus according to claim13, wherein in response to rotation of the spool in the first direction,the respective first end portions of the first and second longitudinalmember portions are configured to be wound around the spool, and,responsively, to pull the respective second end portions of the firstand second longitudinal member portions toward the spool, andresponsively to draw the first and second leaflets toward each other.15. The apparatus according to claim 1, further comprising a mechanicalelement having a surface coupled to the lower surface of the spool, themechanical element being shaped to provide: a protrusion protruding outof a plane of the surface of the mechanical element, the protrusionbeing disposed within one of the recesses during a resting state of themechanical element, in a manner that restricts rotation of the spool,and a depressible portion coupled to the protrusion, the depressibleportion being disposed in communication with the second opening of thelower surface, and configured to dislodge the protrusion from within therecess in response to a force applied thereto by the elongate rotationtool.
 16. The apparatus according to claim 15, further comprising ahousing surrounding the spool, the housing being coupled in part to acap having a surface that is disposed in parallel with the lower surfaceof the spool, and wherein the depressible portion is disposed betweenthe lower surface of the spool and the cap.
 17. The apparatus accordingto claim 15, further comprising a housing surrounding the spool, thehousing being shaped to define a recessed portion thereof configured toreceive the protrusion during the resting state of the mechanicalelement.
 18. The apparatus according to claim 15, further comprising atorque-delivering-tool disposed within a primary lumen of the shaft,wherein the torque-delivering tool is coupled at a distal end thereof tothe elongate rotation tool, and wherein the torque-delivering-tool isconfigured to facilitate rotation of the spool by facilitating rotationof the elongate rotation tool.
 19. The apparatus according to claim 18,wherein: during a first period: the torque-delivering-tool is configuredto maintain the protrusion in a position in which it is dislodged fromthe recess, and the torque-delivering-tool is configured to rotate thespool, and during a second period: the torque-delivering-tool isconfigured to remove the elongate rotation tool from the channel andthereby to position the protrusion in the recess, and in response to thepositioning, the spool is restricted from being rotated.
 20. Theapparatus according to claim 1, wherein: the at least one longitudinalmember comprises at least first and second longitudinal members havingrespective first and second end portions thereof, the first end portionsof the first and second longitudinal members are coupled to the spool,the second end portion of the first longitudinal member is configured tobe coupled to a first portion of tissue of an inner wall of theventricle, the second end portion of the second longitudinal member isconfigured to be coupled to a second portion of tissue of the inner wallof the ventricle, and in response to rotation of the spool, the firstand second longitudinal members are tightened and pull the first andsecond portions of tissue of the inner wall toward one other.
 21. Theapparatus according to claim 1, further comprising an elongate tubecoupled at a first end to the spool and configured, at a second endthereof, to be coupled to subcutaneous tissue of the patient, whereinthe elongate tube is configured to facilitate accessing of atorque-delivering-tool to the spool following (a) the positioning of thespool at the intraventricular site and (b) subsequent removal of thedelivery tool.
 22. The apparatus according to claim 1, wherein: theintraventricular site comprises a second portion of heart tissue thatsurrounds the ventricular space, the spool is configured to be coupledto the second portion of heart tissue that surrounds the ventricularspace, and in response to the rotation of the spool, the longitudinalmember is configured to draw the first and second portions of hearttissue toward each other.
 23. The apparatus according to claim 22,wherein: the first portion of heart tissue includes a first portion ofan inner wall of the ventricle, the second end portion of thelongitudinal member is configured to be coupled to the first portion ofthe inner wall of the ventricle, and in response to the rotation of thespool, the longitudinal member is configured to draw the first portionof the inner wall of the ventricle toward the second portion of hearttissue.
 24. The apparatus according to claim 23, wherein: the secondportion of heart tissue includes a papillary muscle of the ventricle,the spool is configured to be coupled to the papillary muscle, and inresponse to the rotation of the spool, the longitudinal member isconfigured to draw the first portion of the inner wall of the ventricletoward the papillary muscle.
 25. The apparatus according to claim 23,wherein: the second portion of heart tissue includes a second portion ofthe inner wall of the ventricle, the spool is configured to be coupledto the second portion of the inner wall of the ventricle, and inresponse to the rotation of the spool, the longitudinal member isconfigured to draw the first and second portions of the inner wall ofthe ventricle toward one other.
 26. The apparatus according to claim 22,wherein: the first portion of heart tissue includes a leaflet of anatrioventricular valve of the patient, the second end portion of thelongitudinal member is configured to be coupled to the leaflet of theatrioventricular valve of the patient, the second portion of hearttissue includes tissue of a papillary muscle of the ventricle, the spoolis configured to be implanted in the tissue of the papillary muscle ofthe ventricle, and the spool is configured to adjust a length of thelongitudinal member between the papillary muscle and the leaflet of theatrioventricular valve.
 27. The apparatus according to claim 22,wherein: the first portion of heart tissue includes a leaflet of anatrioventricular valve of the patient, the second end portion of thelongitudinal member is configured to be coupled to the leaflet of theatrioventricular valve of the patient, the second portion of hearttissue includes a second portion of an inner wall of the ventricle, thespool is configured to be coupled to the second portion of the innerwall of the ventricle, and the spool is configured to adjust a length ofthe longitudinal member between the second portion of the inner wall andthe leaflet of the atrioventricular valve.